6.3 Review Flags
6.3.1 Record-Level
The comparisons between snapshots are summarized in two ways. The first comparison is at the record level, providing details for every distinct set of key values within each domain. The second set of flags summarizes the record-level flags at the patient level; these flags will be described in the next section. These review flags only describe the relationship between the previous and current data snapshots; they are not intended to describe the history of a record over the course of the clinical trial. System-generated notes can help describe how a record changes over time. Note that the record-level review flags are saved independently of the study database. In other words, no modifications are made to the ...
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